CMS Issues Two QSO Memos on Staff Testing and CLIA Reporting Requirements

CMS; COVID-19
​#1 QSO Memo 20-38-NH: Complying with 483.80(h) Testing of Staff Regulations and New F-tag (F-886)​ 

CMS issued a QSO memo 20-38 that outlines details on how to comply with new interim final rule 483.80(h) requiring COVID-19 testing of staff. AHCA has summarized the guidance, but we recommend members read the entire QSO memo as this regulation goes into effect as soon as the interim final rule is published in the Federal register.  

At a high level, the QSO memo outlines: 

CMS is requiring facilities to conduct three types of testing: 
  • ​Symptomatic Testing: Test any staff or residents who have signs or symptoms of COVID-19 (facility must continue screening all staff, residents and other visitors).
  • Outbreak Testing: Test all staff and residents in response to an outbreak (defined any single new infection in staff or any nursing home onset infection in a resident) and continue to test all staff and residents that tested negative every 3-7 days until 14 days has passed since the most recent positive result.
  • Routine Testing: Test all staff based on the extent of the virus in the community, using CMS’ published county positivity rate in the prior week as the trigger for staff testing frequency (see table below).
Community COVID-19 Activity
County Positivity Rate in the Past Week
Minimum Testing Frequency
​Low
​<5%
​Once a month
​Medium
​5% - 10%
​Once a week*
​High
​>10%
​Twice a week*

*This frequency presumes availability of Point of Care testing on-site at the nursing home or where off-site testing turnaround time is <48 hours. CMS will publish reports of COVID-19 county-level positivity rates here​
  
CMS has also provided requirements related to the following, which are further explained in AHCA’s summary here
  • ​Types of tests (antigen and PCR) 
  • Definition of facility staff (staff and contractors or vendors who regularly provide care and services) 
  • Documenting issues with test supplies and shortages 
  • Dealing with refusals by residents or staff 
  • Reporting requirements  
  • Documenting test results 
  • Conducting tests 
  • Documenting/demonstrating compliance at F886

#2 QSO Memo 20-37-NH: Requirements of Reporting by Clinical Laboratory Improvement Amendments (CLIA) Certified Labs
 
CMS issued a QSO memo 20-37 that describes the survey frequency and citations and fines for not compliance with CLIA regulations related to POC antigen testing. AHCA’s summary is available here.  

Please email COVID19@ahca.org if you have any questions or visit ahcancal.org/coronavirus for more information.